FDA-Device2019-07-31Class II

Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F

Zyno Medical LLC
Hazard

Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified

Sold states
MA
Affected count
360 cases (50/case)=18,000
Manufactured in
177 Pine St, N/A, Natick, MA, United States
Products
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2019

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